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NCT Number: NCT05887661

Goal-directed LCVP Based on HP in Laparoscopic Hepatectomy

The goal of this clinical trial is to learn about goal-directed LCVP based on hypovolemic phlebotomy (HP) in laparoscopic hepatectomy. The main questions it aims to answer are:

1. The safety and feasibility of HP 2. To evaluate whether HP can reduce perioperative blood transfusion ratio Participants undergoing liver resection with HP was performed by the anesthesiologist. Blood was withdrawn approximately 30 min prior to the initiation of liver parenchymal transection from central venous. The aim was to maintain the CVP between 0 to 5 cmH2O. HP volume was 5-10 mL/kg of patient body weight, generally. Participants in control group undergoing liver resection without HP.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location status: Recruiting

Location contact

Shijiang Liu

CONTACT

[email protected]

+86-25-68303569

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of Hepatocellular Carcinoma
  • Preference for laparoscopic hepatectomy and patient agreement

Exclusion criteria

  • Age <18 years
  • Pregnancy
  • Refusal of blood product transfusion
  • Active cardiac conditions (unstable coronary syndromes, decompensated heart failure, significant arrhythmias, severe valvular disease, history of congestive heart failure)
  • History of significant cerebrovascular disease
  • Restrictive or obstructive pulmonary disease
  • Uncontrolled hypertension
  • Renal dysfunction (glomerular filtration rate <60 mL/min),
  • Hemoglobin <100 g/L
  • Abnormal coagulation values (international normalized ratio >1.5 not on warfarin and/or platelet count <100 ×109/L)
  • Evidence of hepatic metabolic disorder (bilirubin >35 mmol/L)
  • Presence of active infection
  • Preoperative autologous blood donation
  • Patients were not allowed to receive erythropoietin at any time during the index hospitalization.

Treatment and study plan

Hypovolemic Phlebotomy

Procedure

hypovolemic phlebotomy was performed after induction of anesthesia and before the star of parenchymal division, with a goal-directed low central venous pressure drop to 5mmHg.

Other names: HP

Primary outcomes

  1. The proportion of allogeneic red blood cell products transfusion

    Time frame: From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 12 months.

    The primary end point of the study was the proportion of patients who required transfusion of allogeneic red blood cell products during laparoscopic hepatectomy or at any time during the hospitalization during the index admission.

Secondary outcomes

  1. The volume of Phlebotomy

    Time frame: From the start of operation until the end of operation.

  2. The volume of Intraoperative blood loss

    Time frame: From the start of operation until the end of operation (during the operation).

  3. The volume of Allogeneic transfusion (perioperative)

    Time frame: From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 12 months.

  4. The volume of Allogeneic transfusion (postoperative)

    Time frame: From the end of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 12 months.

  5. The volume of Allogeneic transfusion (intraoperative)

    Time frame: From the start of operation until the end of operation.

  6. The volume of Fresh frozen plasm (FFP) transfusion

    Time frame: From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 12 months.

  7. The volume of Platelets transfusion

    Time frame: From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 12 months.

  8. The volume of Albumin transfusion

    Time frame: From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 12 months.

  9. Perioperative lowest concentration of Hb

    Time frame: From the start of operation until the date of discharge from hospital or date of death from any cause, whichever came first. assessed up to 12 months.

  10. Pre-transection central venous pressure (CVP), (basic CVP)

    Time frame: From the start of anesthesia induction until the star of operation.

  11. Lowest central venous pressure (CVP)

    Time frame: From the start of operation until the end of operation (during the operation).

  12. time of pringle maneuver

    Time frame: From the start of operation until the end of operation.

  13. number of pringle maneuver

    Time frame: From the start of operation until the end of operation.

    how many patients have the pringle maneuver

  14. operating time

    Time frame: From the start of operation until the end of operation.

  15. The proportion of laparoscopic hepatectomy converted to open liver resection

    Time frame: From the start of operation until the end of operation.

  16. Length of stay

    Time frame: From date of hospitalization until the date of discharge from hospital or date of death from any cause, whichever came first. assessed up to 12 months

  17. Number of Participants with postoperative complications (overall)

    Time frame: From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 1 months.

Study contacts

Contact information is provided by the study sponsor or research team.

Shijiang Liu, MD

CONTACT

[email protected]

+862568303569

Yue Wang

CONTACT

[email protected]

+862568136360

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

The Application of Goal-directed Low Central Venous Pressure Based on Hypovolemic Phlebotomy in Laparoscopic Hepatectomy

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2023
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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